Covid 19 Research using Clinical Trials (Home Page)
Interferon Beta-1AWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug469 | Lopinavir / Ritonavir Wiki | 0.67 |
| drug671 | Questionnaires Wiki | 0.41 |
| drug750 | Single Dose of Hydroxychloroquine Wiki | 0.41 |
| drug429 | Interferon Beta-1B Wiki | 0.33 |
| drug936 | blood sampling Wiki | 0.29 |
| drug775 | Standard of care Wiki | 0.20 |
| drug478 | Lopinavir/ritonavir Wiki | 0.18 |
| drug691 | Remdesivir Wiki | 0.17 |
| drug360 | Hydroxychloroquine Wiki | 0.14 |
Correlated MeSH Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D013577 | Syndrome NIH | 0.09 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.08 |
| D003141 | Communicable Diseases NIH | 0.07 |
| D018352 | Coronavirus Infections NIH | 0.06 |
| D014777 | Virus Diseases NIH | 0.06 |
| D007239 | Infection NIH | 0.05 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 3 clinical trials
Clinical Trials
1 Multi-centre, Adaptive, Randomized Trial of the Safety and Efficacy of Treatments of COVID-19 in Hospitalized Adults
This study is a multi-centre, adaptive, randomized, open clinical trial of the safety and efficacy of treatments for COVID-19 in hospitalized adults. The study is a multi-centre/country trial that will be conducted in various sites in Europe with Inserm as sponsor. Adults (≥18 year-old) hospitalized for COVID-19 with SpO2 ≤ 94% on room air OR acute respiratory failure requiring supplemental oxygen or ventilatory support will be randomized between 4 treatment arms, each to be given in addition to the usual standard of care (SoC) in the participating hospital: SoC alone versus SoC + Remdesivir versus SoC + Lopinavir/Ritonavir versus SoC + Lopinavir/Ritonavir plus interferon ß-1a versus SoC + Hydroxychloroquine. Randomization will be stratified by European region and severity of illness at enrollment (moderate disease: patients NOT requiring non-invasive ventilation NOR high flow oxygen devices NOR invasive mechanical ventilation NOR ECMO and severe disease: patients requiring non-invasive ventilation OR high flow oxygen devices OR invasive mechanical ventilation OR ECMO). The interim trial results will be monitored by a Data Monitoring Committee, and if at any stage evidence emerges that any one treatment arm is definitely inferior then it will be centrally decided that that arm will be discontinued. Conversely, if good evidence emerges while the trial is continuing that some other treatment(s) should also be being evaluated then it will be centrally decided that one or more extra arms will be added while the trial is in progress. The primary objective of the study is to evaluate the clinical efficacy and safety of different investigational therapeutics relative to the control arm in patients hospitalized with COVID-19, the primary endpoint is the subject clinical status (on a 7-point ordinal scale) at day 15.
NCT04315948 Corona Virus Infection Drug: Remdesivir Drug: Lopinavir/ritonavir Drug: Interferon Beta-1A Drug: Hydroxychloroquine Other: Standard of care MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases
Primary Outcomes
Description: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.
Measure: Percentage of subjects reporting each severity rating on a 7-point ordinal scale Time: Day 15Secondary Outcomes
Description: Time to an improvement of one category from admission on an ordinal scale. Subject clinical status on an ordinal scale at days 3, 5, 8, 11, and 29. Mean change in the ranking on an ordinal scale from baseline to days 3, 5, 8, 11, 15 and 29 from baseline.
Measure: Percentage of subjects reporting each severity rating on a 7-point on an ordinal scale Time: Days 3, 5, 8, 11, 15 and 29Description: • Change from baseline to days 3, 5, 8, 11, 15, and 29 in NEWS.
Measure: The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first. Time: Days 3, 5, 8, 11, 15 and 29Measure: Number of oxygenation free days in the first 28 days Time: 29 days
Measure: Incidence of new oxygen use, non-invasive ventilation or high flow oxygen devices during the trial. Time: 29 days
Measure: Duration of new oxygen use, non-invasive ventilation or high flow oxygen devices during the trial. Time: 29 days
Measure: Ventilator free days in the first 28 days Time: 29 days
Measure: Incidence of new mechanical ventilation use during the trial. Time: 29 days
Description: • Duration of hospitalization (days).
Measure: Hospitalization Time: 29 daysDescription: Rate of mortality
Measure: Mortality Time: In hospital, Day 28, Day 90Measure: Cumulative incidence of serious adverse events (SAEs) Time: 29 days
Measure: Cumulative incidence of Grade 3 and 4 adverse events (AEs) Time: 29 days
Measure: Number of participants with a discontinuation or temporary suspension of study drugs (for any reason) Time: 29 days
Measure: Changes from baseline in blood white cell count Time: 29 days
Measure: Changes from baseline in haemoglobin Time: 29 days
Measure: Changes from baseline in platelets Time: 29 days
Measure: Changes from baseline in creatinine Time: 29 days
Measure: Changes from baseline in blood electrolytes (including kaliemia) Time: 29 days
Measure: Changes from baseline in prothrombine time Time: 29 days
Measure: Changes from baseline in international normalized ratio (INR) Time: 29 days
Measure: Changes from baseline in glucose Time: 29 days
Measure: Changes from baseline in total bilirubin Time: 29 days
Measure: Changes from baseline in alanine aminotransferase (ALT) Time: 29 days
Measure: Changes from baseline in aspartate aminotransferase (AST) Time: 29 days
Other Outcomes
Measure: Percent of subjects with SARS-CoV-2 detectable in nasopharyngeal sample Time: Days 3, 5, 8, 11, 15, 29Measure: Quantitative SARS-CoV-2 virus in nasopharyngeal sample Time: Days 3, 5, 8, 11, 15, 29
Measure: Quantitative SARS-CoV-2 virus in blood Time: Days 3, 5, 8 and 11
Description: On Day 1, plasma concentration 4 hours after the first administration (peak), and before the second administration (trough at H12) On Days 3, 5, 8 and 11, trough plasma concentration (before dose administration) while hospitalized
Measure: Plasma concentration of lopinavir Time: Days 1, 3, 5, 8 and 11Description: On Day 1, plasma concentration 4 hours after the first administration (peak), and before the second administration (trough at H12) On Days 3, 5, 8 and 11, trough plasma concentration (before dose administration) while hospitalized
Measure: Plasma concentration of hydroxychloroquine Time: Days 1, 3, 5, 8 and 112 An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial
The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the three arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
NCT04343768 COVID-19 Drug: Hydroxychloroquine Drug: Lopinavir / Ritonavir Drug: Interferon Beta-1A Drug: Interferon Beta-1B
Primary Outcomes
Description: Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.
Measure: Time to clinical improvement Time: From date of randomization until 14 days later.Secondary Outcomes
Description: If the patient dies, we have reached an outcome.
Measure: Mortality Time: From date of randomization until 14 days later.Description: Pulse-oxymetry
Measure: SpO2 Improvement Time: Days 1, 2, 3, 4, 5, 6, 7 and 14.Description: Incidence of new mechanical ventilation use
Measure: Incidence of new mechanical ventilation use Time: From date of randomization until 14 days later.Description: Duration of hospitalization (days)
Measure: Duration of hospitalization Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.Description: With incidence of any serious adverse effects, the outcome has happened.
Measure: Cumulative incidence of serious adverse events Time: Days 1, 2, 3, 4, 5, 6, 7 and 14.3 An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial
The present study is a randomized, double-blind, placebo-controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
NCT04350671 COVID-19 Drug: Interferon Beta-1A Drug: Lopinavir / Ritonavir Drug: Single Dose of Hydroxychloroquine
Primary Outcomes
Description: Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.
Measure: Time to clinical improvement Time: From date of randomization until 14 days later.Secondary Outcomes
Description: If the patient dies, we have reached an outcome.
Measure: Mortality Time: From date of randomization until 14 days later.Description: Pulse-oxymetry
Measure: SpO2 Improvement Time: Days 1, 2, 3, 4, 5, 6, 7 and 14Description: Incidence of new mechanical ventilation use
Measure: Incidence of new mechanical ventilation use Time: From date of randomization until 14 days laterDescription: Duration of hospitalization (days)
Measure: Duration of hospitalization Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.Description: With incidence of any serious adverse effects, the outcome has happened.
Measure: Cumulative incidence of serious adverse events Time: Days 1, 2, 3, 4, 5, 6, 7 and 14.